Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Q4 2023 Earnings Presentation
33 slides from Cardiff Oncology's earnings presentation, Feb 29, 2024
Slide 1: Q4 2023 Financial Results and ONSEMBLE Trial Data
AGENDA Q4 2023 Financial Results and ONSEMBLE Trial Data
Slide 2: Forward-looking statements risks
risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber- attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursem
Slide 3: Agenda
1. 2023 was a transformational year 2. New data release from 2nd line ONSEMBLE trial 3. Review of financial position AGENDA
Slide 4: 2023 was a transformational year
August: mCRC September: beyond mCRC
Slide 5: Our mCRC journey of discovery led us from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE SECOND LINE Ph 1b/2 (TROV-054) COMPLETED KRAS-mutated mCRC 66 evaluable patients, single arm CRDF-004 __ ENROLLING CRDF-003 © ONSEMBL mCRC Clinical Trial DISCONTINUED RAS-mutated mCRC 90 patients, randomized, 3 arms (2 do
Slide 6: Our mCRC journey of discovery led us from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE Provided initial signal of efficacy in second-line RAS-mutated mCRC SECOND Ph 1 b/2 KRAS-mutated mCRC LINE (TROV-054) 66 evaluable patients, single arm COMPLETED
Slide 7: Our mCRC journey of discovery led us from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST Randomized second-line trial LINE designed to show onvansertib’s contribution to SoC that was discontinued SECOND CRDF-003 RAS-mutated mCRC LINE QONSEMBLE forcomied blinded, DISCONTINUED 3 arms (2 doses + control) ONSEMBLE enr
Slide 8: Our mCRC journey of discovery led us from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE SECOND LINE ONSEMBLE e Shift to 1s+line setting based on: | 1. Phase 1b/2 clinical data 2. New mechanism of action 3. FDA recommendation > CRDF-004 __ ENROLLING RAS-mutated mCRC 90 patients, randomized, 3 arms (2 doses +
Slide 9: Existing data, new data, future potential
EXISTING DATA NEW DATA FUTURE POTENTIAL FIRST LINE SECOND LINE
Slide 10: ONSEMBLE trial design
NEW DATA 28 DAY CYCLE ENROLLMENT CRITERIA PRIMARY ENDPOINT
Slide 11: ONSEMBLE's patient demographics reflect second-line mCRC population
ONSEMBLE’s patient demographics reflect second-line mCRC population | NEW DATA CRDF-003 Enrollment* Number of Patients (N) FOLFIRI and bev Intent to Treat 8 Treated (included in safety evaluable patients) 7 Evaluable for efficacy 6 Total Patients N=22 Median [range] or n (%) Age (years) 53 [35-81] S
Slide 12: Bev exposed vs bev naive patients
NEW DATA 1st LINE 2nd LINEBev exposed vs bev naïve patients
Slide 13: Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone NEW DATA ‘CRDF-003 Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Naive Bev Exposed Onvansertib + FOLFIRI / bev Onvansertib + FOLFIRI / bev FOLFIRI / bev alon
Slide 14: Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone NEW DATA ‘CRDF-003 Best Radiographic Response*— @ONSEMBLE patients (as of February 26, 2024) mCRC Clinical Tr Bev Naive Onvansertib + FOLFIRI / bev FOLFIRI / bev alone 100 +68% Objective responses were observe
Slide 15: Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA ‘CRDF-003 Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Exposed Onvansertib + FOLFIRI / bev FOLFIRI / bev alone A a x 100 ‘mm Partial Response mm
Slide 16: Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA ‘CRDF-003 Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) 100 504 % change in target lesions from baseline -100+ mCRC Clinical Trial Bev Naive Bev Exposed FOLFIRI / bev alo
Slide 17: Best response of: PR, SD, PD
NEW DATA Best response of: PR SD PD
Slide 18: Best response of: PR, SD, PD
NEW DATA Best response of: PR SD PD
Slide 19: Two independent clinical trials demonstrate the bev naive finding
Two independent clinical trials demonstrate the bev naive finding NEW DATA CRDF-003 Objective Response Rate (ORR) by Cohort* N Bev Naive Bev Exposed ONSEMBLE Onvansertib 15 50% 0% none # SoC eats vat Control 6 0% 0% (SoC alone) (of 3) (of 3) Phase 1b/2 Onvansertib 66 73% 16% Single-arm + SoC (11 of
Slide 20: Hypoxia, HIF1a and tumor growth
HIF1aα α Tumor growth Hypoxia α
Slide 21: Bevacizumab and onvansertib mechanism
HIF1aαTumor growth Hypoxia α bevacizumab onvansertib α
Slide 22: Future potential
FUTURE POTENTIAL EXISTING DATA NEW DATA FIRST LINE SECOND LINE
Slide 23: Our lead program targets first-line RAS-mutated mCRC
Our lead program targets first-line RAS-mutated mCRC FUTURE POTENTIAL | CRDF-004 mCRC is common... 2024 new US cases ('000s)* © 100 200 300 Breast Prostate Lung Colorectal Melanoma Bladder Renal N-H Lymph. Uterus Pancreas * American Cancer Society Cancer Facts and Figures 2024, and company estimates
Slide 24: CRDF-004 standard of care
FUTURE POTENTIAL Standard of Care
Slide 25: CRDF-004 trial design with Pfizer Ignite
FUTURE POTENTIAL ENROLLMENT CRITERIA ENDPOINTS PFIZER IGNITE 28 DAY CYCLE
Slide 26: Our financial position is strong as of Q4 2023
Our financial position is strong as of Q4 2023 Summary financial information as of December 31, 2023 December 31, 2023 cash and investments* $74.8M Q4 2023 net cash used in Operating Activities* $7.1M Runway with current cash extends into 3Q 2025 We expect to release data from our first-line RAS mut
Slide 27: ONSEMBLE second-line data support our CRDF-004 first-line strategy
ONSEMBLE second-line data support our CRDF-004 first-line strategy Efficacy signal in bev naive patients No SoC signal in the control arm Signal in both 20mg & 30mg dose Results from G)ONSEMBLE Second-line RAS-mut mCRC Objective responses observed only in bev naive patients that received onvansertib
Slide 28: Appendix: Additional ONSEMBLE data
Appendix Additional ONSEMBLE data
Slide 29: Bev naive and bev exposed response
NEW DATA Bev Naïve Bev Exposed B e v N a ïv e B e v E xp o se d
Slide 30: Best response of: PR, SD, PD
NEW DATA Best response of: PR SD PD
Slide 31: Control Arm: Treatment Emergent Adverse Effects (TEAEs)
Control Arm: Treatment Emergent Adverse Effects (TEAEs) | NEW DATA ‘CRDF-003 Control arm (N=7) Patients received FOLFIRI+bev No major/unexpected toxicity seen N (% of total) Any Adverse Events Diarrhea Nausea Fatigue Neutropenia Stomatitis Vomiting Alopecia Constipation Decreased appetite Insomnia H
Slide 32: Onvansertib 30mg Arm TEAEs
Onvansertib 30mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated | NEW DATA ‘CRDF-003 N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total . Any Adverse Events 7 (100.0) 7 (100.0) 4 (57.1) 0( 0.0) 7 (100.0) Experimental arm Diarthea 1(14.3) 1(14.3) 4(57.1) Onv 30mg (N=7) Nau
Slide 33: Onvansertib 20mg Arm TEAEs
Onvansertib 20mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated | NEW DATA CoB O98 N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total A Any Adverse Events 8 (100.0) 7 (87.5) 2( 25.0) 2(25.0) 8 (100.0) Experimental arm Diarrhea 4 (50.0) 3(37.5) 0( 0.0) 0( 0.0) 7 (87.5) Onv